Experimental research

The Alpha Omega Trial is a randomized double-blind placebo-controlled trial carried out in 4,837 patients after a heart attack, in which the hypothesis was tested that low doses of omega-3 fatty acids reduce major cardiovascular and fatal coronary events. The advantage of such a randomized trial is that potential confounders will be evenly distributed over the different intervention groups and therefore do not influence the outcome of the trial. Besides the main hypothesis, other hypotheses could be tested on the effect of omega-3 fatty acids on different endpoints.

Cardiovascular disease endpoints

Cardiovascular diseases claim over 4 million lives in Europe every year. In the Netherlands there are approximately 1 million patients with these diseases out of almost 17 million inhabitants. The number of cardiovascular patients will likely increase due to aging of the population and better survival of the patients because of more effective treatment. The Zutphen Study (www.sevencountriesstudy.com) and other prospective cohort studies provided evidence that fish consumption and the intake of omega-3 fatty acids could protect against cardiovascular diseases. Before statements can be made about the causality of these associations experimental studies are needed to investigate the effect of omega-3 fatty acid supplementation on cardiovascular risk.

Mental health

There is great interest in the prevention of cognitive decline and depression because of the heavy burden of these mental health problems in aging populations worldwide. Prospective cohort studies provide evidence that diet and lifestyle may prevent or postpone cognitive decline and depression. The Zutphen Elderly Study (www.sevencountriesstudy.com) and other prospective cohort studies showed that fish consumption is inversely related to these health problems. In the Alpha Omega Trial we tested the hypotheses that low doses of the fish fatty acids EPA and DHA reduce the risk of cognitive decline and depression.

Intermediate endpoints

In the Alpha Omega Trial we collected blood at baseline and after 40 months of follow-up in a sub-sample of the population. This provided the possibility to test hypotheses on the effects of additional amounts of omega-3 fatty acids on biochemical markers of disease (processes). Examples of these intermediate endpoints are C-reactive protein as an indicator of inflammation, and testosterone and prostate specific antigen as risk factors of prostate cancer.